Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)

April 29, 2014 updated by: CHU de Reims

Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.

  • BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
  • METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
  • EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • AMIENS Cedex 1, France, 80054
        • CHU d'Amiens
      • GRENOBLE Cedex 9, France, 38043
        • CHU de Grenoble
      • MONTPELLIER Cedex 5, France, 34295
        • CHU de Montpellier
      • Marseille, France, 13015
        • AP-HM
      • Nice, France, 06002
        • CHU de Nice
      • PARIS Cedex 18, France, 75877
        • AP-HP - Hôpital Bichat
      • ROUEN Cedex, France, 76031
        • CHU de Rouen
      • STRASBOURG Cedex, France, 67091
        • Hôpitaux Universitaires de Strasbourg
      • Saint-priest-en-jarez, France, 42270
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral emphysema on Chest CT Scanner
  • Post bronchodilator FEV1 < 50 %
  • Total Lung Capacity > 100 %
  • Residual Volume > 220 %
  • Dyspnea score between 2 and 4 based on the mMRC scale
  • Stopped cigarette smoking for more than 8 weeks
  • Pulmonary rehabilitation within the previous twelve months
  • Consent form signed
  • Covered by Medical Insurance

Exclusion Criteria:

  • Post bronchodilator FEV1 < 15%
  • Post-bronchodilator change in FEV1 > 20%
  • Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
  • COPD exacerbation requiring hospital stay within 3 months
  • Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
  • Patient unable to perform a 6-min walking test in room air
  • Giant bulla of more than 1/3 of the lung field on Chest CT
  • Strictly homogeneous emphysema on Chest CT
  • Clinically significant bronchiectasis
  • Past history of lobectomy, lung volume reduction surgery, lung transplantation
  • Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
  • Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
  • Contra-indication to general anesthesia
  • Oral anticoagulant treatment (antivitamin K)
  • Allergy to nitinol
  • Inclusion in an other study assessing respiratory treatments
  • Patient protected by the law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lung volume reduction coïl treatment
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
Procedure: Lung volume reduction coïl treatment
Other: Regular medical treatment
OTHER: Regular Medical Treatment
No intervention, just a follow up under usual medical treatment
Other: Regular medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month improvement of the 6-minute walk test
Time Frame: 6 months
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 6 and 12 months
Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
6 and 12 months
Dyspnea
Time Frame: 6 and 12 months
Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
6 and 12 months
Pulmonary function assessment
Time Frame: 6 and 12 months
Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
6 and 12 months
Quality of life
Time Frame: 6 and 12 months
Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
6 and 12 months
Morbidity-mortality
Time Frame: 6 and 12 months
Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).
6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise testing
Time Frame: 6 and 12 months months
Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).
6 and 12 months months
Exercise testing
Time Frame: 12 months
Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Collaborators

PneumRx, Inc.

Investigators

  • Principal Investigator: Gaëtan DESLEE, PhD, MD, CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (ESTIMATE)

April 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD12133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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